# China NMPA Drug Inspection - Shanxi Huayuan Pharmaceutical Biotechnology Co., Ltd. - Telmisartan capsules

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanxi-huayuan-pharmaceutical-biotechnology-co-ltd/a4980be7-ca86-490b-b36a-382ef29e7183/
Source feed: China

> China NMPA drug inspection for Shanxi Huayuan Pharmaceutical Biotechnology Co., Ltd. published June 03, 2021. Drug: Telmisartan capsules. On June 3, 2021, the Hebei Provincial Drug Administration published its first quality bulletin for 2021, detailing non-c

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: Hebei Province Drug Quality Bulletin (2021 Drug Supervision and Sampling Inspection No. 1)
- Company Name: Shanxi Huayuan Pharmaceutical Biotechnology Co., Ltd.
- Publication Date: 2021-06-03
- Drug Name: Telmisartan capsules
- Inspection Finding: The [content determination] item did not meet the requirements.
- Action Taken: The relevant drug regulatory authorities have taken control measures such as sealing and seizing in accordance with the law, initiated an investigation, and taken necessary risk control measures.
- Summary: On June 3, 2021, the Hebei Provincial Drug Administration published its first quality bulletin for 2021, detailing non-compliance discovered during routine sampling inspections of manufacturers and distributors. The inspection identified substandard Telmisartan Capsules (batch number 190507) produced by Shanxi Huayuan Pharmaceutical Biotechnology Co., Ltd. The product, sampled from Gucheng County Bencao Tang Pharmacy, failed the 'Content Determination' requirement, indicating that the level of active ingredients did not meet established safety and efficacy standards. In accordance with the Drug Administration Law of the People's Republic of China, regulatory authorities have already implemented enforcement measures, including the seizure and sealing of the affected medication. The administration has mandated the investigation and prosecution of Shanxi Huayuan Pharmaceutical Biotechnology Co., Ltd. for the production and sale of substandard pharmaceuticals. Required actions include implementing immediate risk control measures and publicly announcing the results of the enforcement actions within a three-month period. Additionally, authorities are directed to trace the source of any potentially counterfeit drugs and refer cases involving suspected criminal activity to the public security department for further prosecution. All findings must be formally reported to the provincial inspection department to ensure regulatory compliance and safeguard public health.

Company: https://www.globalkeysolutions.net/companies/shanxi-huayuan-pharmaceutical-biotechnology-co-ltd/32869502-7aa3-4fa8-8d89-854fb28aca1e/